Information Update - Health Canada advises of a second impurity linked to recalled valsartan drugs

OTTAWA, Sept. 13, 2018 /CNW/ - Health Canada is advising Canadians that a second impurity, called N-nitrosodiethylamine (NDEA) has been found in valsartan manufactured by Zhejiang Huahai Pharmaceuticals in China.

All drugs containing valsartan manufactured by Zhejiang Huahai Pharmaceuticals have already been recalled in Canada after the first impurity, N-nitrosodimethylamine (NDMA), was identified earlier this summer. Both NDEA and NDMA are classified as probable human carcinogens, which means that long-term exposure could cause cancer.

Health Canada advised Canadians about the recalls in July and August 2018. Health Canada also recently advised Canadians of its health risk assessment related to valsartan products containing NDMA.

The new information regarding NDEA is very limited at this time. Health Canada is assessing the issue and will update Canadians as more information becomes available, including whether the presence of NDEA impacts Health Canada's health risk assessment related to valsartan products containing NDMA.

Drugs containing valsartan are used to treat patients with high blood pressure to help prevent heart attacks and stroke. These drugs are also used in patients who have had heart failure or a recent heart attack.

Health Canada is working with the European Medicines Agency, the United States Food and Drug Administration, and other international regulatory partners to determine the root cause of the issue and confirm that necessary actions are taken to address the risk to health and prevent this situation from happening again. Health Canada will continue to keep Canadians informed as new information becomes available.

What you should do
People taking valsartan drugs should check these lists of valsartan products that have and have NOT been recalled to see whether their medication is affected.

Patients taking affected valsartan medications should:

• Ask their pharmacist if they are unsure whether they are using a recalled product.
• Contact their health care provider as soon as possible to discuss treatment options if they have been using an affected product. Pharmacists may be able to provide a product not affected by the recall, or doctors may prescribe a different medication for their patients' conditions.
• Continue taking their valsartan medication unless they have been advised to stop by their health care provider. Since the risk of cancer is with long-term exposure to the NDMA and NDEA impurities, there is no immediate health risk, and patients can continue to take this drug to treat their medical condition until they can discuss treatment options with their health care provider.
• Contact their health care provider if they have taken recalled valsartan products and they have concerns about their health.

Related Links

• European Medicines Agency NDEA announcement
• Health Canada information update (2018-09-10): Valsartan NDMA Health Risk Assessment
• Health Canada information update (2018-08-18): Teva Canada expands recall of valsartan drugs to include additional lots, as a precaution
• Health Canada advisory (2018-07-09): Several drugs containing valsartan being recalled due to contamination with a potential carcinogen

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SOURCE Health Canada

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